Confocal Laser Endomicroscopy As an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
- Conditions
- Pancreatic Cyst
- Registration Number
- NCT03492151
- Brief Summary
The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Patient age 18 years or older
- All patients referred for EUS-FNA of accessible PCL where surgery is contemplated
- Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies
- Unable to obtain informed consent
- Unable to tolerate the procedure
- Women with known pregnancy at time of procedure
- Patient age less than 18 years
- Bleeding diathesis
- Known allergy to fluorescein
- Prior pancreatic cancer
- Prior pancreatic surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of PCL diagnosis 48 months Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
Accuracy of risk-stratification of IPMNs 48 months Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
- Secondary Outcome Measures
Name Time Method Imaging quality 48 months Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions
Trial Locations
- Locations (10)
Parkview Hospital Randallia
🇺🇸Fort Wayne, Indiana, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
NYU Langone Health
🇺🇸Garden City, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Mayo Clinic Scottsdale Campus
🇺🇸Scottsdale, Arizona, United States
Stanford Hospital
🇺🇸Stanford, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States